Systems and mechanisms for deploying a docking device for a replacement heart valve

ABSTRACT

Systems and methods usable in delivering a docking device to a native valve of a patient&#39;s heart. A distal region of a delivery catheter can be positioned in an atrium of the heart and a distal tip can be positioned at or near a commissure of the native valve. The docking device can be located within the delivery catheter. A pusher, such as a pusher wire or tube, of a pusher tool can be advanced distally through the delivery catheter, wherein the pusher can push the docking device along within the delivery catheter. The docking device can be connected to the pusher tool by a line, such as a suture. A member of the pusher tool can be rotatable to change the amount of the suture extending from the pusher tool.

RELATED APPLICATIONS

The present application is a continuation of PCT Patent ApplicationSerial No. PCT/US2017/066865 titled “SYSTEMS AND MECHANISMS FORDEPLOYING A DOCKING DEVICE FOR A REPLACEMENT HEART VALVE” filed on Dec.15, 2017, which claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/436,695, filed on Dec. 20, 2016 and U.S.Provisional Patent Application Ser. No. 62/560,962, filed on Sep. 20,2017. The entire disclosures of these applications are incorporatedherein by reference in their entirety.

FIELD

The present disclosure generally relates to medical devices andprocedures pertaining to prosthetic heart valves which replace thefunctionality of native valves that may have malformations and/ordysfunctions and associated devices, such as anchoring or dockingdevices.

BACKGROUND

Referring first to FIGS. 1 and 2, the mitral valve 51 controls the flowof blood between the left atrium 52 and the left ventricle 54 of thehuman heart and, similarly, the tricuspid valve 53 controls the flow ofblood between the right atrium and the right ventricle. For example,after the left atrium 52 receives oxygenated blood from the lungs viathe pulmonary veins, the mitral valve 51 permits the flow of theoxygenated blood from the left atrium 52 into the left ventricle 54.When the left ventricle 54 contracts, the oxygenated blood that was heldin the left ventricle 54 is delivered through the aortic valve 56 andthe aorta 58 to the rest of the body. Meanwhile, the mitral valve shouldclose during ventricular contraction to prevent any blood from flowingback into the left atrium.

When the left ventricle contracts, the blood pressure in the leftventricle increases substantially, which serves to urge the mitral valveclosed. Due to the large pressure differential between the leftventricle and the left atrium during this time, a large amount ofpressure is placed on the mitral valve, leading to a possibility ofprolapse, or eversion of the leaflets of the mitral valve back into theatrium. A series of chordae tendineae 62 therefore connect the leafletsof the mitral valve to papillary muscles located on the walls of theleft ventricle, where both the chordae tendineae and the papillarymuscles are tensioned during ventricular contraction to hold theleaflets in the closed position and to inhibit them from extending backtowards the left atrium. This helps prevent backflow of oxygenated bloodback into the left atrium. The chordae tendineae 62 are schematicallyillustrated in both the heart cross-section of FIG. 1 and the top viewof the mitral valve of FIG. 2.

A general shape of the mitral valve and its leaflets as viewed from theleft atrium is shown in FIG. 2. Commissures 64 are located at the endsof the mitral valve 51 where the anterior leaflet 66 and the posteriorleaflet 68 come together. Various complications of the mitral valve canpotentially cause physical problems, including fatal heart failure. Oneform of valvular heart disease is mitral valve leak or mitralregurgitation, characterized by abnormal leaking of blood from the leftventricle through the mitral valve back into the left atrium. This canbe caused, for example, by dilation of the left ventricle and/or mitralvalve annulus causing the native mitral leaflets not to coaptcompletely, resulting in a leak or regurgitation. This can also lead toproblems with the native leaflets, and/or weakening of (or otherproblems with) the chordae tendineae and/or papillary muscles, which canin turn lead to mitral regurgitation. In these circumstances, it may bedesirable to repair the mitral valve or to replace the functionality ofthe mitral valve with that of a prosthetic heart valve.

However, there has been limited research devoted to developingcommercially available ways to replace a mitral valve through catheterimplantation and/or other minimal or less invasive procedures, insteadof via open-heart procedures. This may stem from mitral valvereplacement being more difficult than aortic valve replacement inrespects not accounted for by aortic valve replacement technology, forexample, due to the non-circular physical structure of and moredifficult access to the mitral annulus. Since transcatheter aortic valvetechnology is more developed, it could be beneficial to adapt similarcircular valve prostheses for mitral applications.

A prominent obstacle for mitral valve replacement is effective anchoringor retention of the valve at the mitral position, due to the valve beingsubject to a large cyclic load. Especially during ventricularcontraction, the movement of the heart and the load or pressure on thevalve can combine to shift or dislodge an inadequately anchoredprosthetic valve. In addition, the movement and rhythmic load can easilyfatigue the implant, leading to fractures or other damage to theimplant. Even a slight shift in the alignment of the valve may lead tothe blood flow through the valve being negatively affected. Meanwhile,puncturing the tissue in or around the mitral valve annulus to betteranchor the implanted valve can lead to unintended perforation of theheart and patient injury.

Another issue with mitral and tricuspid valve replacement is the sizeand shape of the native annulus. For example, a circular or cylindricalreplacement valve similar to replacement aortic valves may not fit themitral position. A replacement valve that is too small or the wrongshape may cause leaks around the implanted valve (i.e., paravalvularleak), if a good seal is not established around the valve. A replacementvalve that is too large may stretch out and damage the native annulus.Furthermore, the presence of the chordae tendineae and other anatomy canform obstructions that make it more challenging to adequately anchor adevice at the mitral position. Also, significant variations in anatomyof a mitral and/or tricuspid valve from patient to patient make itdifficult to have a solution that will work for all or at least a widevariety of patients.

SUMMARY

This summary is meant to provide some examples and is not intended to belimiting of the scope of the invention in any way. For example, anyfeature included in an example of this summary is not required by theclaims, unless the claims explicitly recite the features. Also, thefeatures described can be combined in a variety of ways. Variousfeatures and steps as described elsewhere in this disclosure may beincluded in the examples summarized here.

One way to apply circular or cylindrical transcatheter valve technology(e.g., as may be used with aortic valve replacement) to non-circularvalve replacement (e.g., mitral valve replacement, tricuspid valvereplacement, etc.) would be to use an anchor (e.g., a coiled anchor,helical anchor, mitral anchor, etc.) or docking device/docking stationthat forms or otherwise provides a more circular or cylindrical dockingsite at the native valve position (e.g., mitral valve position) to holdsuch prosthetic valves.

The anchoring or docking devices themselves can be designed for deliveryvia a transcatheter approach. One such anchoring or docking device is acoil or anchor that includes a helically shaped region that has aplurality of turns defining a circular or cylindrical inner space fordocking the prosthesis or bioprosthesis, e.g., THV. In this manner,existing expandable transcatheter valves developed for the aorticposition, or similar valves that have been slightly modified to moreeffectively replicate native valve function (e.g., native mitral valvefunction), could be more securely implanted in such a dockingdevice/station positioned at the native valve annulus (e.g., nativemitral annulus).

The docking device/station can first be positioned at the native valveannulus, and thereafter, the prosthesis (e.g., valve implant ortranscatheter heart valve) can be advanced and positioned through thedocking device/station while in a collapsed position, and can then beexpanded, for example, via self-expansion (e.g., in the case of valvesthat are constructed with NiTi or another shape memory material),balloon expansion, or mechanical expansion, so that the frame of theprosthetic valve pushes radially against the docking device/stationand/or tissue between the two to hold the valve in place.

Preferably, the docking device/station can also be delivered minimallyor less invasively, for example, via the same or similar approaches(e.g., transcatheter approaches) as used for delivery of a prostheticvalve (e.g., a transcatheter heart valve), so that a completely separateprocedure is not needed to implant the docking device/station prior todelivery of the prosthetic valve. Such docking devices can alsopotentially be used at any of the heart's native valves, for example, atthe tricuspid, pulmonary, or aortic positions, to provide more secureimplantation of prosthetic valves at those sites as well.

Deployment tools can be used to deliver these anchors or anchoringdevices (e.g., coiled or helical anchoring devices) to an implant siteprior to delivery of the THV, to provide a more stable foundation orsupport structure into or against which the THV can be expanded orotherwise implanted. For example, a guide sheath and/or deliverycatheter can be advanced through a patient's vasculature, so that adistal end of the delivery catheter is positioned at or near the implantsite. The anchor or docking device can then be advanced through and/orout of the delivery catheter and transitioned and/or adjusted to adesired shape and position at the implant site. Optionally, a shape ofthe distal region of the delivery catheter can also be bent, angled, orotherwise adjusted to facilitate easier or more proper positioning ofthe anchor or docking device at the implant site. A handle of thedelivery catheter can be designed to allow a practitioner or other enduser to easily control the shape and/or movements of the distal regionof the delivery catheter.

An advancement tool or mechanism (e.g., a pusher tool) can be part of asystem for delivering the anchoring or docking device and can be used tophysically push or otherwise advance the anchoring or docking devicethrough and/or out of the delivery catheter. Pusher tools or otherpushing mechanisms that provide an easy and effective way to advance ananchoring device through a delivery catheter to an implant site aredescribed. Optionally, the pusher tool can also facilitate retractionand/or retrieval of the helical anchor back into the delivery catheter,for example, to reposition or remove the anchoring/docking device.

Delivery devices and systems for delivering a coiled anchoring device toa native valve annulus of a patient's heart can include variousfeatures, including those described in various locations in thisdisclosure. The anchoring device can be configured to secure aprosthetic heart valve at the native valve annulus. The delivery devicesand systems can include a delivery catheter having a longitudinal axisand a distal region configured or adjustable/transitionable to curve ina plane (e.g., in a plane that intersects the longitudinal axis).

The delivery devices and systems can also include a pusher tool. Thepusher tool can have a pusher (e.g., comprising a pusher wire, pushertube, etc.) connectable (indirectly or directly) to the deliverycatheter on a side opposite the distal region of the delivery catheter.For example, the delivery catheter can include a handle or beattached/connected to a handle that is connected or connectable to thepusher tool and/or pusher. Optionally, the pusher tool and/or pusherdoes not need to connect directly or fixedly to the catheter handle ordelivery catheter, but can merely have the pusher or pusher wireinserted therethrough.

The pusher tool can include a body and a pusher. The body can beconfigured to be rotationally fixed relative to the delivery catheter orbe configured such that the pusher tool and/or pusher can be fixed orlocked (e.g., to a stabilizer) such that the pusher tool and/does notrotate relative to the delivery catheter. The pusher tool can include acontrol (e.g., knob, button, tab, input, etc.) connected to the bodyand/or a pusher (e.g., a pusher wire or tube). In one embodiment, thecontrol is a knob rotatable relative to the body, and the pusher isconnected to the knob. The pusher (e.g., pusher wire or pusher tube) canbe configured to extend through the body to the delivery catheter, andto move translationally and/or axially in the delivery catheter when thecontrol is actuated (e.g., when the knob is rotated relative to thebody) to move an anchoring device that is held in the delivery catheter.

Methods of delivering a docking device or anchoring device (e.g., ahelical or coiled anchoring device) to a native valve of a patient'sheart can include a variety of steps, including steps disclosed invarious locations in this disclosure. For example, the methods caninclude obtaining and/or providing an anchoring device/docking device(e.g., a coiled or helical anchoring device), a delivery catheter, aguide sheath, a pusher tool and/or pusher, and/or various systems,devices, and/or other components. The anchoring device can be configuredto secure a prosthetic heart valve at the native valve.

In one embodiment, the methods include positioning a distal region of adelivery catheter in an atrium of the heart, adjusting or transitioningthe delivery catheter to a first position and/or configuration where thedistal region of the delivery catheter curves at least partially aroundthe native valve and/or positioning a distal opening of the deliverycatheter at or near a commissure of the native valve.

A pusher or pusher wire/tube is used to push all or part, such as afirst portion (e.g., an encircling turn/coil and functionalturns/coils), of the anchoring device out of the distal opening of thedelivery catheter and into a ventricle of the heart. This can be donewhile holding the delivery catheter at the first position. The guidesheath, delivery catheter, pusher tool/pusher can be fixed or held inposition at a proximal end by locking or securing the proximal end or ahandle/body at the proximal end in a stabilizer (e.g., a stabilizationdevice).

Where the pusher or pusher wire/tube includes a pusher tool having aknob (or other control) that can move and/or control the pusher orpusher wire/tube, the methods include rotating the knob (or otherwiseactuating a control) of the pusher tool in a first direction to advancethe pusher or pusher wire/tube distally through the delivery catheterwhile the delivery catheter is held at the first position. As the knobis rotated (or control is actuated) and the pusher or pusher wire/tubeis advanced distally, the pusher or pusher wire/tube can push all orpart, such as a first portion (e.g., an encircling turn/coil andfunctional turns/coils), of the anchoring device out of the distalopening of the delivery catheter and into the ventricle. This caninclude pushing the anchoring device through the commissure of thenative valve, if the distal opening is positioned on the atrial side ofthe commissure.

Where the previous step only involves using the pusher or pushertube/wire to push a first portion out of the distal end of the catheter(e.g., while the delivery catheter is held stationary), the methods theninvolve releasing a second portion (e.g., a stabilization coil/turn oratrial coil/turn) of the anchoring device from the delivery catheter.This can be done in a variety of ways. For example, the pusher tool,pusher, and/or pusher wire/tube can be locked or fixed in position(e.g., by locking or fixing a proximal end thereof, such as in astabilizer, and/or by locking/holding/maintaining the knob in position),while the delivery catheter is pulled or retracted proximally. This canhold the anchoring device in position (e.g., because it abuts thestationary pusher or pusher wire/tube) while unsheathing it from thedelivery catheter. If a guide sheath is used, the guide sheath can alsobe locked/fixed in position (e.g., in the stabilizer) while the deliverycatheter is retracted.

Optionally, if the system is so configured, rotating a body of thepusher in a direction opposite to the first direction while holding aposition of the knob (e.g., wherein the body of the pusher and thedelivery catheter are rotationally fixed relative to one another suchthat the knob holds a position of the anchoring device at the nativevalve while the rotation of the body also rotates the distal region ofthe delivery catheter) causes proximal movement of the delivery catheterto release the second portion of the anchoring device from the distalopening of the delivery catheter into the atrium.

In one embodiment, delivery devices and systems for delivering ananchoring or docking device to a native valve annulus of a patient'sheart comprise a delivery catheter and a pusher tool. The deliverycatheter has at least one lumen (e.g., a first lumen) and can havemultiple lumens, e.g., 2-6 lumens. The pusher tool comprises a pusher orpusher wire or tube. The pusher tool can also include a suture or line(e.g., a connecting or retrieval suture/line) and/or a suture or linelock or locking mechanism. The pusher tool can also include a rotatablemember. The pusher or pusher wire or tube is slideably received withinthe first lumen. The pusher or pusher wire or tube has a distal portionand a proximal portion, and can have a lumen (e.g., a pusher lumen orsecond lumen) extending from the proximal portion to the distal portion.

The suture or line lock or locking mechanism can have any of thefeatures/components described in various locations in this disclosure.For example, the suture/line lock or locking mechanism can be attachedto the proximal portion of the pusher or pusher wire or tube. The sutureor line (e.g., retrieval suture or line) can extend through the lumen(e.g., pusher lumen/second lumen) from the suture or line lock orlocking mechanism to the docking device to connect the anchoring ordocking device to the pusher tool.

The suture/line lock or locking mechanism can include a rotatable memberconnected to the suture or line (e.g., the retrieval suture or line).The rotatable member can be lockable in position in a variety of ways,for example, the rotatable member can have a first position (e.g., alocked or non-rotational position) that locks the amount of suture orline (e.g., the retrieval suture or line) that extends from the lock orlocking mechanism and can have a second position (e.g., a movable orrotational position) that allows the amount of retrieval suture or linethat extends from the lock or locking mechanism to be increased ordecreased.

Methods of delivering an anchoring or docking device to a native valveof a patient's heart can include additional steps. For example, a distalregion of a delivery catheter can be positioned in an atrium of theheart. The anchoring/docking device can be positioned or located withinthe delivery catheter. A pusher (e.g., a pusher wire or tube) of apusher tool can be advanced distally through the delivery catheter, suchthat the pusher pushes and/or pulls the anchoring/docking device withinand/or into or out of the delivery catheter (e.g., the pusher tool canbe used to push the anchoring/docking device axially or distally withinand/or out of the delivery catheter, and the pusher tool can be used topull/retract the anchoring/docking device axially or proximally intoand/or within the delivery catheter). The docking device can beconnected to the pusher tool by a connector, e.g., a suture or line(e.g., optionally, using a suture/line lock or locking mechanism thesame as or similar to those described in various locations in thisdisclosure). A member (e.g., a rotatable member) of the pusher tool canbe rotated to change the amount of the suture extending from the pushertool.

A replacement valve, for example, at the mitral or tricuspid position,can be held more securely through the use of a separateanchoring/docking device that provides a more stable docking site forthe replacement valve. The anchoring/docking device is delivered througha delivery catheter, and a pusher tool or other pushing mechanism isused to provide easier control in advancing, retracting, positioning,and/or repositioning of the anchoring device at the implant site. Thepusher tool can include a pusher, such as a pusher wire or pusher tube.

A pusher or pusher wire/pusher tube can be configured to extend throughany of the delivery catheters disclosed herein. The pusher wire/tube canhave a plurality of sections, and each of the plurality of sections canhave a different stiffness. A first section of the of the pusherwire/tube can have a first stiffness, a second section of the pusherwire/tube can have a second stiffness, and a third section of the pusherwire/tube can have a third stiffness. The stiffness of the first sectioncan be less than the stiffness of the second section, which can be lessthan the stiffness of the third section. The pusher wire/tube can beconstructed of hypotube, polymer tube, coil pipe, coil spring, flexibletube, wire, rod, etc. One or more sections (e.g., the third section) ofa pusher tube can be constructed of an uncut hypotube. One or moresections (e.g., the first section, second section, and/or third section)of a pusher tube can be constructed of a hypotube having interruptedcuts. The frequency and/or size of the interrupted cuts can change alongthe length of the hypotube. The pusher wire/tube can further include acover (e.g., a polymer cover, fabric cover, etc.).

In one embodiment, the pusher tool includes a distal portion and aproximal portion, a lumen extending from the proximal portion to thedistal portion, and an opening at the distal portion. A line or suture(e.g., a retrieval line/suture) extends through the lumen to connect thepusher tool to a proximal end of a docking device. The line/suture(e.g., retrieval line) can be threaded through a hole near the proximalend of the docking device thereby connecting the docking device to thepusher tool. The line/suture (e.g., retrieval line) can be threaded fromthe distal end of the pusher tool back through the central lumen to aproximal region of the pusher tool. First and second ends of theretrieval line can be connected to the proximal portion of the pushertool. The pusher tool can further include a pusher or pusher wire/tube.The pusher or pusher wire/tube can have a distal end comprising abraided layer. The pusher tool can have a pusher or pusher wire/tubethat includes a distal end having a soft layer. The pusher tool canfurther have a pusher or pusher wire/tube that includes a distal endhaving a rounded or curved tip region.

The pusher tool can further comprise a suture or line lock or lockingmechanism, which can have any of the features/components described invarious locations in this disclosure. In one embodiment, the lock orlocking mechanism includes a body having a first portion, a secondportion extending away from a central region of the first portion, and arotatable member connected to and rotatable relative to the firstportion of the body. The lock or locking mechanism can further include ahandle at a first end of the body that extends from a side of the firstportion of the body. The handle can facilitate turning the rotatablemember relative to the first portion of the body. The lock or lockingmechanism further includes an engagement feature at a second end of thebody opposite the handle, wherein the engagement feature connects atleast one end of the line/suture to the body. The lock or lockingmechanism can further include a bore extending through the secondportion of the body and connecting the first portion of the body with adistal opening of the body. The bore creates a pathway from the secondportion of the body to the first portion of the body, wherein thepathway can allow the line to engage the rotatable member. Theline/suture is anchorable using the engagement feature. Rotating thehandle can be used to adjust an amount of the line that is wound aroundthe rotatable member. The lock or locking mechanism can further includea window in the second portion that exposes a portion of the line. Thelock or locking mechanism can further include a seal cap connected tothe second portion of the body.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages of the invention will become apparentfrom the description of embodiments using the accompanying drawings. Inthe drawings:

FIG. 1 shows a schematic cross-sectional view of a human heart;

FIG. 2 shows a schematic top view of a mitral valve annulus of a heart;

FIG. 3 shows a perspective view of an exemplary helical anchoring ordocking device;

FIGS. 4A to 4D show partial perspective views of an exemplary methodused for implanting an anchoring or docking device at a native valve ofa heart, using a transseptal technique;

FIG. 5 shows a cross-sectional view of an exemplary anchoring or dockingdevice positioned at the native valve of the heart prior to delivery ofa prosthetic heart valve;

FIG. 6 shows a cross-sectional view of the anchoring or docking deviceand a prosthetic heart valve finally implanted at the native valve ofthe heart;

FIG. 7 shows a perspective view of a distal section of an exemplarydelivery catheter useable for implanting an anchoring or docking deviceat a native valve;

FIG. 8 shows a perspective view of an exemplary catheter handle of adelivery catheter that can be used to control the delivery catheter orportions thereof;

FIG. 9 shows a perspective view of an exemplary pusher tool, where thepusher tool is useable to advance the anchoring or docking devicethrough and/or out of a delivery catheter;

FIG. 10 shows a perspective and partial cross-sectional view of thepusher tool of FIG. 9;

FIG. 11 shows an enlarged and partial cross-sectional view of a sectionof the pusher tool of FIGS. 9 and 10, including portions of the pusherwire and a pathway for advancing and retracting the pusher wire relativeto the rest of the pusher tool;

FIG. 12 shows an enlarged view of another section of the pusher tool ofFIGS. 9 and 10, including portions of an exemplary pusher wire and aslot for holding the pusher wire;

FIG. 13 shows a schematic view of an exemplary pusher tube;

FIG. 14 shows a partial cross-sectional view of a distal tip of a pushertube/wire that is connected to a proximal end of an anchoring or dockingdevice;

FIG. 15 shows a perspective and partial cross-sectional view of anexemplary pull wire or suture/line lock or locking mechanism for apusher tool;

FIGS. 16A and 16B show a first step of an exemplary method of deliveringan anchoring or docking device using an exemplary pusher tool;

FIGS. 17A and 17B show a second step of the exemplary method ofdelivering the anchoring or docking device using the pusher tool;

FIG. 18 shows a schematic representation of an exemplary system fordelivering an anchoring or docking device, shown with the anchoring ordocking device within a delivery catheter and engaging a pusher or apusher wire or tube;

FIG. 19 shows a schematic representation of an exemplary system fordelivering an anchoring or docking device, shown with the anchoring ordocking device outside a delivery catheter and engaging a pusher or apusher wire/tube;

FIG. 20 shows a schematic representation of an exemplary embodiment of asystem for delivering an anchoring or docking device, shown with theanchoring or docking device outside a delivery catheter and disengagedfrom the pusher wire or tube;

FIG. 21 shows a perspective view of an exemplary embodiment of a pushertool that can be used in the system of FIGS. 18-20, including asuture/line lock or locking mechanism;

FIG. 22 is a side sectional view of the pusher tool of FIG. 21;

FIG. 23 is an exploded view a rotatable member and a housing of thesuture/line lock or locking mechanism of FIG. 21;

FIG. 24 is a sectional view of the rotatable member and a housing ofFIG. 23;

FIG. 25 is a side sectional view of an exemplary suture/line locklocking mechanism in a first position;

FIG. 26 is a top sectional view of the suture/line lock or lockingmechanism of FIG. 25; and

FIG. 27 is a side sectional view of the suture/line lock or lockingmechanism of FIG. 25 in a second position.

DETAILED DESCRIPTION

The following description and accompanying figures, which describe andshow certain embodiments, are made to demonstrate, in a non-limitingmanner, several possible configurations of systems, devices,apparatuses, components, methods, etc. that may be used for variousaspects and features of the present disclosure. As one example, varioussystems, devices/apparatuses, components, methods, etc. are describedherein that may relate to mitral valve procedures. However, specificexamples provided are not intended to be limiting, e.g., the systems,devices/apparatuses, components, methods, etc. can be adapted for use inother valves beyond the mitral valve (e.g., in the tricuspid valve).

Disclosed herein are embodiments of deployment tools that are intendedto facilitate implantation of prosthetic heart valves at one of thenative mitral, aortic, tricuspid, or pulmonary valve regions of a humanheart, as well as methods of using the same. The prosthetic valves canbe expandable transcatheter heart valves (“THVs”). The deployment toolscan be used to deploy anchoring or docking devices that provide a morestable docking site to secure prosthetic valve (e.g., THVs) at thenative valve region. The deployment tools include a pusher tool ormechanism that facilitates easier and more accurate delivery andpositioning of the anchoring device at the implant site, so that theanchoring devices and the THVs anchored thereto can function properlyafter implantation.

An example of an anchor/anchoring device/docking device is shown in FIG.3, though other configurations or variations are also possible.Anchoring or docking device 1 is a coil that is substantially helical orincludes coils that are helical with a plurality of turns extendingalong a central axis of the docking device 1, where the coil(s) can havevarious differently sized and shaped sections. The docking device 1 isconfigured to best fit at the mitral and tricuspid positions, but can beshaped similarly or modified in other embodiments for betteraccommodation at other native valve positions as well. U.S. patentapplication Ser. No. 15/682,287 and U.S. patent application Ser. No.15/684,836 include additional examples and details of anchors/anchoringdevices/docking devices that can be used with the systems, devices,apparatuses, methods, etc. in this disclosure, and each of theseapplications is incorporated by reference in their entirety.

The docking device 1 includes a central region/portion 10 withapproximately three full coil turns having substantially equal innerdiameters. The turns of the central region 10 provide the main landingor holding region for holding the THV upon implantation, and aretherefore sometimes referred to as the functional coils of the anchoringdevice 1, since the properties of these coils contribute most to theretention of the valve prosthesis relative to the docking device 1 andthe native anatomy. A size of the coils of the central region 10 isgenerally selected to be slightly smaller than the outer diameter of theTHV after expansion, to generate a sufficient radial forces or tensionbetween the central region and the THV to fix them relative to oneanother and/or pinch native tissue (e.g., native leaflets and/orchordae) therebetween.

The docking device 1 is positionable in the native valve annulus (e.g.,native mitral or tricuspid valve annulus) by rotating or cork-screwing adistal or leading tip (e.g., from the right or left atrium) through thenative valve annulus (e.g., into the right or left ventricle). Since thesize of the coils of the central region 10 is kept relatively small, thedocking device 1 further includes a distal or lower region/portion 20that forms a leading or encircling coil/turn (e.g., a leadingventricular coil) of the docking device 1. The lower region 20 has adiameter that is greater than the diameter of the central region 10 sothat the distal tip is positioned wider relative to the central axis ofthe docking device 1, in order to more easily navigate the distal tip ofthe docking device around the features of the native anatomy, such asthe chordae tendineae. When the distal tip is navigated around thedesired anatomy, the remaining coils, which are smaller, can be guidedaround the same features, thereby encircling and corralling theanatomical features slightly inwardly. The lower region 20 can be keptrelatively short to reduce flow disturbances.

The anchoring or docking device can optionally include a low-frictionsleeve, e.g., a PTFE sleeve, that fits around all or a portion (e.g.,the leading and/or functional turns) of the anchoring or docking device.For example, the low-friction sleeve can include a lumen in which theanchoring or docking device (or a portion thereof) fits. Thelow-friction sleeve can make it easier to slide and/or rotate theanchoring or docking device into position with less-friction and beingless likely to cause abrasions or damage to the native tissue than thesurface of the anchoring or docking device. The low-friction sleeve canbe removable (e.g., by pulling proximally on the sleeve while holding apusher and the docking device in place) after the anchoring or dockingdevice is in position in the native valve, e.g., to expose the surfaceof the anchoring or docking device, which can be or include portionsconfigured (porous, braided, large surface area, etc.) to promote tissueingrowth.

The docking device 1 also includes an enlarged proximal or upper region30 that makes up a stabilization coil (e.g., an atrial coil) of thedocking device. The enlarged upper region 30 is sized and shaped to abutor push against the walls of native anatomy (e.g., the walls of achamber of the heart or atrium), in order to improve the ability of thedocking device 1 to stay in its desired position once it has beendelivered to the implant site and prior to implantation of the THV. Thedocking device 1 can optionally also include a generally verticalextension 40 connecting the central region 10 and the upperregion/portion 30, and serving as a vertical spacer for spacing apartand forming a vertical gap between the upper region 30 and the otherportions of the docking device 1. In this manner, the amount of thedocking device 1 that pushes against the native annulus can be reduced,thereby reducing stress on the native tissue. The docking device 1 canalso have one or more through holes 50 at or near a free proximal end ofthe upper region 30. The through holes 50 can serve, for example, as anattachment site for a delivery tool such as a pusher tool, pull wire,suture, etc.

Other embodiments of docking devices can have more or less turns in eachof the described regions, or some regions (e.g., the enlarged upperregion 30) can be omitted altogether. In some cases, widths orthicknesses of the coil of the docking device can also be varied alongthe length of the docking device, based for example, on desiredstrengths and curvatures of certain coil regions. In some embodiments,additional layers, for example, a high friction cover layer, can also beadded to the docking device to facilitate more effective delivery and/orimplantation/retention. Meanwhile, while a direction of the turns of thedocking device 1 are arranged for counter-clockwise advancement into theventricle, the coils can optionally be wound in the opposite directionto facilitate clockwise advancement instead.

The docking device 1 is generally flexible, and can be made of orinclude, for example, a shape memory material, so that the coils of thedocking device 1 can be straightened for delivery through a deliverycatheter. For mitral applications, the docking device 1 can be deliveredto the mitral position, for example, transatrially from the left atrium,transseptally through the atrial septum, or via one of various otherknown access points or procedures (e.g., transapically, etc.).

Various methods and steps can be used for delivering a docking device toa native heart valve. For example, U.S. patent application Ser. No.15/682,287 and U.S. patent application Ser. No. 15/684,836, eachincorporated by reference, describe various methods and steps that canbe used. Also, FIGS. 4A to 6 show steps of an exemplary method that canbe used for delivering a docking device 1 to the mitral position using atransseptal approach, where a delivery system/device 400 is advancedthrough the atrial septum of the heart. Referring first to FIG. 4A, theinteratrial septum can be punctured, for example, at the fossa ovalis,and a larger guide sheath 480 of the delivery system/device 400, whichfor example, houses and protects delivery catheter 410, can first beadvanced through the puncture hole and into the left atrium. In FIG. 4B,a distal region of a delivery catheter 410 is advanced out of a distalopening of the guide sheath 480 positioned in the left atrium in asubstantially straight or unactuated configuration. In tricuspidprocedures, it is generally unnecessary to puncture, cross, or advancethrough the septum.

Thereafter, when in a desired region or first chamber of the heart(e.g., right or left atrium), as shown in FIG. 4C, the distal region ofthe delivery catheter 410 itself can be bent or otherwise actuated toprepare for delivery of the docking device 1. The distal region of thedelivery catheter 410 can take various shapes based, for example, on theshape of the anchoring or docking device, the delivery site, and/or thepatient's anatomy. For example, the delivery catheter 410 in FIGS. 4Cand 4D delivers the docking device 1 in a clockwise direction near theA1P1 commissure.

In one embodiment, for example, as shown in FIG. 7, the distal region ofthe delivery catheter 410 includes a first substantially straightportion 412 extending from the guide sheath 480, followed distally by ashallow curved portion 414 to bend the distal region of the deliverycatheter 410 towards the mitral plane. The shallow curved portion 414 isfollowed by a circular portion 416 that curves in a counter-clockwisedirection (or optionally a clockwise direction) around and substantiallyplanar to the native annulus (e.g., mitral or tricuspid annulus) toprovide a general delivery path for the docking device 1. Distal to thecircular portion 416 can further be a flexible end portion 418 that canbe angled or pointed slightly downwards. The flexible end portion 418can be used to point the distal opening of the delivery catheter 410downwards towards and/or into a commissure, for example, commissure A3P3of the mitral valve, to facilitate easier advancement of the dockingdevice 1 into another or second chamber of the heart (e.g., the leftventricle or right ventricle). The distal opening can be positionedadjacent the commissure and the anchoring or docking device pushed outof the opening and through the commissure, or the distal opening can bepositioned at or just past the commissure such that the anchoring ordocking device is pushed out of the opening directly into the secondchamber.

The delivery catheter 410 can include multiple control or pull wires(e.g., 2-6 pull wires) arranged and configured such that applyingtension to the control/pull wires causes the distal region of thedelivery catheter 410 to curve and/or shape as desired. In oneembodiment, at least two control/pull wires run through a wall of thedelivery catheter and terminate at different locations in the distalregion such that each control/pull wire causes a different portion ofthe distal region to curve when tensioned or pulled. The wires can bepulled directly or have controls (e.g., handles, tabs, knobs, buttons,inputs, and/or other components) for imparting tension and/or relaxingtension of the control wires/pull wires.

Referring again to FIG. 4C, after the distal region of the deliverycatheter 410 has been actuated to a delivery position, a first stage ofcoil delivery can be performed, where the docking device 1 is extrudedor pushed out from a distal opening of the delivery catheter 410,through the native valve (e.g., mitral or tricuspid valve, such asthrough a commissure of the valve), and into the second chamber or leftventricle. The distal end of the docking device 1 can then be rotatedaround to encircle at least some of the anatomy in the second chamber orventricle (e.g., leaflets and/or chordae) to corral the anatomy withinthe coils of the docking device 1. This advancement of the dockingdevice 1 through and/or out of the delivery catheter 410 can beaccomplished, for example, with a pusher tool 430 according toembodiments of the invention, as will be described in more detail below.During delivery, the docking device 1 can be held in the deliverycatheter 410 in a straightened or relatively straight configuration foreasier maneuverability through the delivery catheter 410. Thereafter, asthe docking device 1 exits the delivery catheter 410, the docking device1 can return to its original or shape-memory coiled or curved shape.

After a desired amount of the docking device 1 has been advanced intothe second chamber of the heart (e.g., left or right ventricle), therest of the docking device 1 can then be deployed or released into thefirst chamber of the heart (e.g., left or right atrium) during a secondstage of coil delivery. FIG. 4D shows one method of releasing the upperportion or stabilization coil/turn (e.g., atrial portion) of the dockingdevice 1 into the first chamber (e.g., left or right atrium). In FIG.4D, the distal region of the delivery catheter 410 is pulled and/orrotated backwards, while the docking device 1 is held at substantiallythe same position and orientation, until the entire docking device 1 isreleased from the delivery catheter 410. For example, when the dockingdevice 1 is advanced clockwise out of the delivery catheter 410 as shownin FIG. 4C, the delivery catheter can thereafter be pulled (and/orrotated counter-clockwise), as shown in FIG. 4D, to release the upperportion or stabilization coil/turn (e.g., atrial portion) of the dockingdevice 1 therefrom. The pusher tool 430 can be adjusted during thisprocedure to extrude and/or push out the anchoring or docking device 1from the delivery catheter 410 and/or pull/retract the delivery catheterwhile a position of the docking device 1 relative to the native anatomy(e.g., mitral or tricuspid anatomy) is maintained. In this manner, alower portion (e.g., ventricular position) of the docking device 1 doesnot have to be adjusted or readjusted during or after delivery of theupper portion (e.g., atrial portion) of the docking device 1. Variousother methods of releasing the upper portion of the docking device 1 canalso be employed in other embodiments.

After the docking device 1 is fully deployed and adjusted to a desiredposition at the implant site, any connections between the pusher tool430 and the docking device 1 (e.g., connection sutures) can be detached,and the delivery device 400 can be removed from the implant site. FIG. 5shows a cross-sectional view of a portion of a patient's heart with thedocking device 1 implanted at the mitral position and prior to deliveryof the THV. The enlarged upper portion/region or stabilization turn/coil30 of the docking device 1 pushes against the first chamber walls (e.g.,atrial walls) to help temporarily hold the docking device 1 at a desiredposition. The THV is then advanced through and expanded in the dockingdevice 1. The THV can be advanced using the same or a different deliverycatheter.

FIG. 6 shows a cross-sectional view of a portion of the heart with boththe docking device 1 and a THV 80 finally implanted at the mitralposition. Similar positioning can be accomplished in the tricuspidvalve. Generally, the THV 80 will have an expandable frame structure 81that houses a plurality of valve leaflets 82 (e.g., artificial and/orpericardial leaflets). The expandable frame structure 81 can, forexample, be self-expanding, mechanically expandable, or balloonexpandable. Upon expansion, radial pressures between the THV 80 and thedocking device 1, as well as with the surrounding anatomy, securely holdthe entire assembly in place at the native valve position (e.g., mitralor tricuspid position).

As discussed above, FIG. 7 shows a perspective view of a distal sectionof the delivery catheter 410 in an exemplary actuated delivery state,but other actuated delivery states are possible. Control or actuation ofthe distal section of the delivery catheter 410 can be accomplished, forexample, through various controls that are integrated into a handle thatis connected to a proximal end of the delivery catheter 410. FIG. 8shows a perspective view of an embodiment of a catheter handle 420connected to the delivery catheter 410. The catheter handle 420 includesan elongated main body that is connected to the delivery catheter 410 atits distal end 420 a. The main body of the catheter handle 420 providesa central lumen or tubular bore extending therethrough (not shown) thatis connected to the delivery catheter 410, to provide access to thedelivery catheter 410 from a proximal end 420 b of the catheter handle420.

The catheter handle 420 can further include two controls 422, 424configured to adjust the shape or otherwise actuate the distal region ofthe delivery catheter 410, for example, to the configuration shown inFIG. 7 or another configuration with two regions/portions curved indifferent dimensions. A first control 422 can be arranged in the form ofa knob that can rotate around the catheter handle 420 (e.g., coaxialwith the handle), and can control, for example, an internal threadedmember (not shown) that increases or decreases the tension in a firstcontrol wire or pull wire connected to a first region (e.g., a firstdistal region) of the delivery catheter 410. The first control knob 422(or optionally the second control knob 424)) can be used to adjust theshallow curved portion 414 for aligning the first region of the deliverycatheter 410 with the plane of the native valve annulus for example, themitral plane. Meanwhile, a second control 424 can also be arranged inthe form of a knob that can also rotate around the catheter handle 420(e.g., coaxial with the handle). The second control knob 424 can controlanother internal threaded member (not shown) that increases or decreasesthe tension in a second control wire or pull wire that is connected to asecond region (e.g., a second distal region or a region distal to ordistally adjacent to the first region) of the delivery catheter 410, forexample, to bend the circular portion 416 around the native valveannulus. In this manner, the handle can independently control the degreeof flexion or actuation in multiple dimensions (e.g., in each of theshallow curved portions 414 and the circular portion 416), for moreprecise positioning and delivery of the docking device 1. Additionalcontrol wires or pull wires are also possible as discussed previously,and these can be similar to those discussed here and can be controlledwith additional controls or knobs similar to controls 422, 424 or withthe same controls.

The handle can, optionally, also include one or more indicators, such asindicators 422 a, 424 a, that respectively identify an amount of flexionor actuation of the delivery catheter 410 effected by each of thecontrols (e.g., by controls 422, 424). The indicators 422 a, 424 a, caneach be, for example, a window that is integrated into the catheterhandle 420, with a level indicator and a key which identifies how mucheach control is actuating the delivery catheter 410. In someembodiments, a position of an internal feature associated with thecontrols 422, 424, for example, the internal threaded members whichtranslate axially relative to the catheter handle 420 when one of thecontrols 422, 424 is turned, can also serve as a level indicator throughthe indicators 422 a, 424 a. In this manner, the delivery catheter 410can be more precisely controlled or adjusted. In some embodiments, athird controller is also included to control the distal end portion 418,or the control of the distal end portion 418 can be integrated into oneof the existing controllers, for example, the second control 424.

The catheter handle 420 can also include additional features. Forexample, in FIG. 8, the catheter handle 420 includes a collet mechanism426 that can lock, for example, a position of a pusher body, a pusherwire, or other component relative to the catheter handle 420. In FIG. 8,the proximal end 420 b of the handle further includes a proximal sealand flushing port 428 to facilitate easy flushing of the handle,delivery catheter 410, and/or other components of the delivery device400. In other embodiments, a handle for controlling the deliverycatheter 410 can include any of various other features which can assistin facilitating more precise and/or better handling of the deliverycatheter 410.

While the above features of the catheter handle 420 facilitate thecontrol of the distal region of the delivery catheter 410 in preparationfor delivering the docking device 1, another tool or mechanism can beused to physically advance and retract the docking device 1 through thedelivery catheter 410 and/or maintain its position.

FIG. 9 shows a perspective view of an exemplary pusher tool 430, andFIG. 10 shows a perspective and partial cross-sectional view of thepusher tool 430 of FIG. 9. The pusher tool 430 in FIGS. 9 and 10 ispresented schematically, and it is to be understood that a pusher tool430 can either be an entirely separate tool from the catheter handledescribed above with respect to FIG. 8, or in some embodiments, can beintegrally formed with or combined with other embodiments of catheterhandles. For example, in some embodiments, the catheter handle 420 inFIG. 8 can be designed to have an integrated pusher mechanism withfeatures similar to or the same as the pusher mechanism discussed below,so that a separate pusher tool is not needed.

Referring to FIGS. 9 and 10, an exemplary pusher tool 430 can include ahandle body 440, a knob 450, and/or a pusher wire or tube 460. Whilevarious features/components and arrangements are described as examples,all the described features/components and arrangements are not required.For example, one embodiment can have a handle body 440 and a knob 450that can rotate relative to each other to cause translational or axialmovement of these components relative to each other, while anotherembodiment may not have one or both of these features and/or thesefeatures may not be arranged for relative axial or translationalmovement. One embodiment can just have a knob that rotates a rotationalmember and a pusher wire/tube that can wrap/wind on or off therotational member to extend or retract in the delivery catheter. Thepusher tool could also have a body with a fixed relationship to thepusher wire/tube that does not involve rotation or winding. The pushertool can be connectable or not connectable to the delivery catheter.

As shown in the illustrated example in FIG. 10, the handle body 440 canhave an elongated and generally cylindrical profile. A central bore 441can extend from a proximal end of the handle body 440 towards a distalend of the handle body 440. The central bore 441 can define a generallycylindrical space within the handle body 440, into which a base 451 ofthe knob 450 can extend. The distal end of the central bore 441 can beclosed, and can have a portion 442 that is also substantiallycylindrical, with a reduced diameter compared to that of the rest of thecentral bore 441. In addition, between the portion 442 and the otherportions of the central bore 441, an engagement feature 443, such as aprojection or a groove, can be formed at an inner wall of the handlebody 440. The portion 442 of the bore 441 and/or the engagement feature443 can be utilized to help attach the handle body 440 with the knob450.

The handle body 440 can, optionally, also define a tunnel or pathway 444that connects the central bore 441 with the distal end of the handlebody 440. The tunnel 444 can include a first region 445 that extendssubstantially tangentially from the cylindrical profile of the centralbore 441 (see, e.g., FIG. 11), and can include a second region 446 thatturns from the first region 445 towards the distal end of the handlebody 440, to provide a pathway for the pusher or pusher wire 460 to runfrom the central bore 441 to the distal end of the handle body 440. Ascan also be seen in FIG. 11, in some embodiments, an inner wall of thehandle body 440 can also include a guiding key 447, which can be a smallprojection, to guide the movement of the knob 450 relative to the handlebody 440. Meanwhile, at the distal end of the handle body 440, a bore,luer, or other structural feature 448 can be provided for attaching andfixing the handle body 440 to other parts of the delivery device 400,for example, to a delivery catheter 410 or a catheter handle 420. Insome embodiments, the body of the handle shell 440 is a monolithicpiece, while in other embodiments, the handle body 440 can be multiplepieces, for example, two halves that can be assembled together.

Meanwhile, the knob 450 of the pusher or pusher tool 430 can include abase 451, an enlarged head region 452 at one end for easier handling androtating by a practitioner or other end user, and a knob support 453 atan opposite end for connecting the knob 450 to the handle body 440. Thebase 451 of the knob 450 can be substantially cylindrical and sized forinsertion into the central bore 441 of the handle body 440. A diameterof the base 451 can be slightly smaller than a diameter of the centralbore 441, so that the base 451 fits snugly in, and can still turn orrotate while positioned in, the central bore 441.

Near a distal end of the base 451 of the knob 450, a slot or canal 454can be formed in an exterior surface of the base 451 and can extendmultiple times around the exterior surface of the base 451 in aspiraling or helical manner. The slot 454 can be sufficiently sized tohold the pusher or pusher wire 460 therein, so that the pusher wire 460also wraps around the base 451 of the knob 450 in a spiraling or helicalmanner while held in the slot 454. In some cases, the spiraling shapethe pusher wire 460 is held in is similar to a shape and size of thedocking device 1 (e.g., of a portion of the docking device 1) when thedocking device 1 is deployed, which can facilitate easier shaping of thepusher wire 460 through the curved distal portions of the deliverycatheter 410 during delivery of the docking device 1. Furthermore, whenthe handle body 440 and the knob 450 are connected, the slot 454 can bepositioned fully within the central bore 441 of the handle body 440.Therefore, due to a snug fit between the central bore 441 of the handlebody 440 and the base 451 of the knob 450, the slot 454 can besubstantially enclosed by the handle body 440 and the knob 450, so thatportions of the pusher wire 460 that are held in the slot 454 areentirely supported in all radial directions around a central axis of thepusher tool 430, preventing the pusher wire 460 from spreading out of orotherwise escaping the slot 454 of the knob 450, and ensuring properfunctionality of the pusher tool 430.

Meanwhile, as can best be seen in FIG. 12, a plurality of ribs 455 canbe formed in the knob 450 that extend transversely into the slot 454. Inthe embodiment shown, the ribs 455 are arranged in pairs that extendfrom opposite sides of the slot 454 towards one another, and a pluralityof such pairs of ribs 455 are positioned at intervals along at leastpart of the length of the slot 454. In other embodiments, other ribarrangements can be formed in the slot 454, so long as the pusher wire460 can extend through the slot 454 past each of the ribs 455. The ribs455 increase a friction or abutting force between the pusher wire 460and the knob 450, which results in a higher pushing ability or forcethat the pusher wire 460 can impart on the docking device 1, whencompared for example, to a pusher tool where the only push force orabutting force is applied at a proximal end of the pusher wire by thepusher tool.

At one end of the base 451, the knob 450 can have an enlarged headregion 452. The enlarged head region 452 can be adapted for easyhandling and rotation by a practitioner or other end user. In theembodiment shown, the enlarged head region 452 is also cylindrical, witha diameter that is greater than a diameter of the base 451, and includesa plurality of longitudinal ribs or gripping features for improved grip.The enlarged head region 452, in other embodiments, can be designed withdifferent shapes and sizes, so long as safe and easy handling andmanipulation of the knob 450 relative to the handle body 440 can beachieved.

Referring back to FIG. 10, the knob support 453 shown is a cylindricalor tubular piece that extends away from the base 451 of the knob 450 ona side opposite the enlarged head region 452, with a diameter that isless than the diameter of the base 451. The knob support 453 can connectthe knob 450 to the handle body 440. For example, the knob support 453can be sized to fit inside the smaller distal portion 442 of the centralbore 441 of the handle body 440, and can have a circumferentiallyextending groove 456 that is configured to engage the projectingengagement feature 443 of the handle body 440, to prevent the knobsupport 453, as well as the rest of the knob 450, from falling out ordisconnecting from the handle body 440. In some embodiments, thelocations of the groove and projection can be switched, or otherengagement features can be utilized, so long as the knob 450 can freelyturn relative to the handle body 440. The knob support 453 can beaxially movable relative to the rest of the knob 450, so that the knob450 can still move axially relative to the handle body 440 in order tomaintain alignment of the respective pathways for the pusher wire 460.The knob support 453 can extend, for example, into a bore formed at adistal end of the base 451 of the knob 450, and an additional engagementfeature (not shown) holds the knob support 453 and the rest of the knob450 together. In one embodiment, the knob support 453 is formedmonolithically with the rest of the knob 450, where the engagementbetween the knob support 453 and the handle body 440 can be modified toallow the knob support 453 to also move axially relative to the handlebody 440.

The pusher or pusher wire 460 can connect the docking device 1 to therest of the pusher tool 430, and can be the part or one of the partsthat physically pushes or otherwise deploys, and in some embodiments,pulls or otherwise retrieves, the docking device 1 relative to thedelivery catheter 410. As can be seen most clearly in FIG. 12, theexemplary pusher wire 460 in the figure is shown as being constructed asa spring wire formed by a compact and fully contracted spring.Respective diameters of the physical wire that forms the spring, as wellas of the structure of the pusher wire 460 as a whole, can be selectedto give the pusher wire 460 enough flexibility to wrap around and turntogether with the knob 450, and with enough stiffness to push and/orresist retraction of the docking device 1 during deployment of thedocking device 1, while avoiding portions of the pusher wire 460collapsing longitudinally inside either the tunnel 444 of the handlebody 440 or the slot 454 of the knob 450. In embodiments where thepusher wire 460 is constructed as a spring wire, the surface of thepusher wire 460 can also provide additional engagement features thatinteract with the ribs 455 in the slot 454, which can further enhancethe pushing force of the pusher tool 430.

Optionally, pushers or pusher wires/tubes can be constructed in any ofvarious different manners. For example, the pusher or pusher wire/tubecan be constructed with or include a polymer tube, can be a laser cuthypotube with a polymer cover, can be a coil pipe or spring, or can beconstructed with or include any other form of flexible tube, so long asaxial pressures can be applied against the pusher or pusher wire/tubewith minimal or no axial compression, so that the pushing of the dockingdevice 1 is not compromised by the construction of the pusher or pusherwire 460.

In one embodiment, illustrated in FIG. 13, an exemplary pusher or pushertube/wire 460′ is constructed using a hypotube that is laser cut orotherwise cut to provide for multiple sections (e.g., three sections)with different flexibility. The pusher 460′ illustrated by FIG. 13 canbe used separately from the pusher tool 430 illustrated by FIGS. 9-12. Afirst section 461′ can be formed with an uncut hypotube, so that thefirst section 461′ forms a stiffest portion of the pusher or pusher tube460′. A second section 462′ adjacent to the first section 461′ can beformed by cutting a hypotube with an interrupted cut, and theinterrupted cut can, optionally, have axial intervals that decrease in adirection from the first section 461′ towards a third section 463′. Inthis manner, the second section 462′ is stiffer in a region closer tothe first section 461′, where the intervals between the cuts are larger,and more flexible towards the third section 463′, where the intervalsbetween the cuts are smaller. Lastly, the third section 463′ can beformed by cutting the hypotube with an interrupted cut (e.g., aninterrupted cut that stays constant at a small interval), so that thethird section 463′ is the most flexible of the three sections of thepusher or pusher tube 460′. In this or a similar manner, a pusher orpusher tube 460′ can be customized so that some portions provide forstronger support, while other portions allow for more flexibility, forexample, portions of the pusher 460′ near the distal tip which maneuverthrough the distal turns of the delivery catheter 410. In otherembodiments, different flexible sections can be formed in variousdifferent manners. In some embodiments, a small portion near the distalend of the pusher 460′ can be left uncut, to impart extra strength tothe distal tip 464′ of the pusher 460′.

Referring now to FIG. 14, a pusher or pusher wire/tube 460 has a distalend 464 that is constructed in an atraumatic manner. Either thepusher/pusher wire 460 discussed with respect to FIGS. 9 to 12 or thepusher/pusher tube 460′ discussed with respect to FIG. 13, or any otherpusher or pusher wire/tube, can employ a distal end 464 similar to orthe same as that shown in FIG. 14. An atraumatic tip portion can beformed, for example, by adding an additional braided or othercomparatively soft layer 465 to the distal end 464, and/or by forming arounded or otherwise more curved tip region, to prevent damage to thedocking device 1, any connecting sutures, the delivery catheter 410,and/or the patient's anatomy.

Furthermore, in some embodiments, the docking device 1 can be physicallyattached or connected to the distal end 464 of the pusher 460, 460′, inorder to maintain connection and/or enable retrieval or pulling of thedocking device 1 relative to the delivery catheter 410. As shown in FIG.14, the pusher 460 (or 460′) can be formed with a central lumen 466extending therethrough and an opening 467 at the distal tip of thepusher 460. Lumen 466 and opening 467 can provide a passageway throughwhich a retrieval or connecting line (e.g., a retrieval or connectingsuture) or other connecting feature can pass, in order to connect thepusher or pusher wire/tube to a proximal end of the docking device 1. Asshown in FIG. 14, a connecting or retrieval line/suture 468 can bethreaded through lumen 466, out of opening 467, and through a hole nearthe proximal end of the docking device 1, to connect the docking device1 to the pusher 460. The retrieval line/suture 468 can be threaded fromthe distal end 464 of the pusher 460 back through the central lumen 466,and up to a proximal region of the pusher tool 430. In one embodiment,the two ends of the retrieval line/suture 468 can be anchored at orconnected to a handle or other portion of the pusher tool 430, forexample, to a locking knob 457 located on the enlarged head region 452of the knob 450 (see, e.g., FIG. 9). The locking knob 457 can provideeasy access to the ends of the retrieval line/suture 468, where forexample, severing the retrieval or connecting line/suture 468 and/orpulling one side of the retrieval line/suture 468 until the retrievalline/suture 468 passes out of the through hole 50 on the docking device1 disconnects the docking device 1 from the pusher or pusher wire/tube.

In another embodiment, shown in FIG. 15, an exemplary locking knob orexemplary suture/line lock or locking mechanism is shown. The suturelocking mechanism or line locking mechanism 470 in FIG. 15 can be acomponent that is added to an existing assembly, for example, anassembly that does not have an integrated suture locker. In someembodiments, the suture/line lock or locking mechanism 470 itself isintegrated with other portions of a pusher or pusher tool 430. Thesuture/line locker 470 can be used without the pusher tool 430illustrated by FIGS. 9-12. For example, the suture locker 470 can beused with the pusher or pusher tube 460′ illustrated by FIG. 13, withoutthe pusher tool illustrated by FIGS. 9-12. The suture lock or locker 470can include a generally T-shaped body having a first portion 471 and asecond portion 472 that extends away from a central region of the firstportion 471.

A rotatable member 473 can be connected through and rotatable relativeto the first portion 471 of the body, and can have a handle 474 at oneend that extends outside of the first portion 471 of the body. Thehandle 474 can facilitate turning or rotating of the rotatable member473 relative to the first portion 471 of the body. On an end of therotatable member 473 opposite the handle 474, an engagement feature 475can be provided for anchoring or holding one or more ends of theconnecting or retrieval line/suture 468 thereto. Meanwhile, a bore 476can extend through the second portion 472 of the body to connect thefirst portion 471 of the body with a distal opening of the body. Thebore 476 can create a suture route or pathway that allows the retrievalline/suture 468 to extend through the second portion 472 to the firstportion 471 of the body, where the retrieval line/suture 468 can engagethe rotatable member 473. Here, the retrieval line/suture 468 can bepassed through or over the rotatable member 473, and can be anchoredusing the engagement feature 475. When the retrieval line/suture 468 isanchored to the rotatable member 473, the rotatable member 473 can actas a spool for the retrieval line/suture 468, such that rotating thehandle 474 adjusts an amount of the retrieval line/suture 468 that iswound around the rotatable member 473, for increasing or decreasing aworkable length and/or tension of the retrieval line/suture 468. Aslot/window/cut-out 469 can be formed in the suture/line lockingmechanism 470 (e.g., in the second portion 472), and theretrieval/connecting line/suture 468 can form a loop with one end orportion of the suture or loop extending over, across, and/or through theslot/window/cut-out 469, such that the portion is exposed in theslot/window/cut-out 469 and can be cut by running a knife/scalpel alongthe slot/window/cut-out. Cutting the line/suture in this manner canbreak the loop and/or release the line/suture such that it can bewithdrawn and pulled out from the docking device 1, thereby releasingthe docking device 1.

Latching and/or other locks/locking mechanisms can also be incorporatedinto the suture/line locking mechanism 470 for maintaining a position ortension of the retrieval line/suture 468. In some embodiments, thesuture/line lock or locking mechanism 470 further includes a seal cap477 for connecting the suture/line lock or locking mechanism 470 toother components of the delivery device 400, and for example, formaintaining homeostasis through the delivery device 400 when thedelivery device 400 is in use.

Referring back to FIGS. 10 and 11, when the respective parts of thepusher tool 430 are assembled together, complementary features betweenthe various components also help facilitate a smoother and more robustoperation of the pusher tool 430. For example, a first region 445 of thetunnel 444 in the handle body 440 is positioned to be aligned with theslot 454 of the knob 450, and to extend at a tangent to the spiralingwrapping direction of the slot 454. In this manner, the pusher or pusherwire/tube 460 can extend, advance, and retract seamlessly between theslot 454 on the knob 450 and the first region 445 of the tunnel 444 inthe handle body 440, without any turns or direction changes between thecomponents.

Additionally, guiding key 447 on handle body 440 can also be positionedalong the spiraling wrapping direction of the slot 454, for example,slightly distally to the opening into the first region 445 of the tunnel444. The guiding key 447 can be configured, sized and shaped to allowthe guiding key 447 to extend into the slot 454, and allow the slot 454to slide over the guiding key 447. When the guiding key 447 ispositioned slightly distally to the first region 445 of the tunnel 444into which the pusher wire 460 extends, portions of the slot 454 thatreach the guiding key 447 are empty and do not hold the pusher or pusherwire/tube 460. In this manner, the guiding key 447 can act as a track orguide for the axial positioning of the knob 450 relative to the handlebody 440, and prevent excess axial shifting therebetween. In thismanner, the guiding key 447 can always ensure that the slot 454 isconcentered and axially aligned with the tangential first region 445 ofthe tunnel 444 when the knob 450 is turned. The design of the pushertool 430 also facilitates storing of a relatively long pusher or pusherwire/tube 460 in a relatively compact space in handle body 440. Forexample, in one embodiment, a handle with a length of only about 20 cmcan house and deploy a pusher or pusher wire/tube 460 with a functionallength or travel length of up to 80 cm.

Operation of the pusher tool in an exemplary method will now bedescribed in connection with delivery of a docking device to a nativemitral valve, with reference to FIGS. 16A to 17B. The pusher tool 430shown is intended to be used together with a catheter handle, forexample, catheter handle 420, which can be locked together with at leastthe handle body 440 of the pusher tool 430. In some embodiments, thehandle body 440 of the pusher tool 430 is integrally formed with thecatheter handle 420. However, in each embodiment, the handle body 440 ofthe pusher tool 430 and catheter handle 420 can be coupled together, sothat the catheter handle 420, the delivery catheter 410, and the handlebody 440 of the pusher tool 430 are rotated concurrently. Therefore,when the knob 450 of the pusher 430 is held stationary, rotation of thecatheter handle 420 will cause the distal region of the deliverycatheter 410 to rotate, while simultaneously also rotating the handlebody 440 of the pusher tool 430 relative to the knob 450, resulting ineither advancing or retracting of the pusher or pusher wire/tube 460relative to the delivery catheter 410 depending on the direction ofrotation. This arrangement provides for full control of the dockingdevice 1 relative to the delivery catheter 410 during both deploymentand retrieval of the docking device 1.

Referring now to FIGS. 16A and 16B, after the distal region of thedelivery catheter 410 has been actuated or adjusted to an appropriatedelivery configuration, the handle body 440 of the pusher tool 430 (andthe catheter handle 420 if one is present) can be held stationary orfixed while the knob 450 is rotated, for example, in a clockwisedirection relative to the other portions of the delivery device 400.Rotation of the knob 450 can unwrap the pusher or pusher wire/tube 460from the slot 454 of the knob 450 (see, e.g., FIG. 10) and advance thepusher or pusher wire/tube 460 through the dedicated passageway formedby the tunnel 444 and out of the distal end of the handle body 440. Thisshifts the pusher or pusher wire/tube 460 distally relative to thedelivery catheter 410, and consequently pushes the distal end of thepusher or pusher wire/tube 460 against the proximal end of the dockingdevice 1 to advance the docking device 1 distally out of the distalopening of the delivery catheter 410. As described above, the dockingdevice 1 can be released from or pushed out of the delivery catheter 410at an orientation that is substantially coincident with, or angledslightly downward relative to, the plane of the native valve annulus,and is then advanced through the native valve. For example, in themitral valve, the docking device 1 is advanced through a commissure ofthe valve, and into the left ventricle. Optionally, all or only a firstportion of the anchoring/docking device is advanced and/or deployed atthe native valve or native annulus in this way.

The various anchoring/docking devices, delivery catheters, and/or guidesheaths described in various locations in this disclosure can includeone or more radiopaque markers to aid in delivery and proper positioningof the anchoring/docking device, delivery catheter, and/or guide sheath.For example, viewing the relative movement and location of a radiopaquemarker on the anchoring/docking device and a radiopaque marker on thedelivery catheter can indicate when a predetermined or first portion(e.g., the encircling turn/coil and/or some or all of the functionalturns/coils) of the anchoring/docking device has been pushed out of thedelivery catheter and into the native annulus. In one example, anoperator can rotate the knob and/or advance the pusher wire/tube suchthat the pusher wire/tube advances the anchoring/docking device untilthe predetermined or first portion of the anchoring/docking device hasbeen deployed into the native annulus by watching the relative movementof the radiopaque marker on the anchoring/docking device and theradiopaque marker on the delivery catheter (e.g., watching for when theyare aligned, which can indicate the first portion has been properlydeployed from the delivery catheter).

Once a desired amount or the predetermined or first portion of theanchoring/docking device (which can be determined with the use of one ormore radiopaque markers on the docking device and/or delivery catheteras discussed above) of the docking device 1 has been advanced into thechamber of the heart or ventricle (e.g., left ventricle or rightventricle) and the predetermined or first portion (e.g., the ventricularcoils or encircling and/or functional coils) of the docking device 1have been positioned satisfactorily or at the native annulus, a secondportion (e.g., a stabilization coil/turn or atrial coil/turn) of theanchoring device can be delivered or deployed from the deliverycatheter. This can be done in a variety of ways.

For example, the knob 450 and/or pusher tool can be held stationary orfixed, so that the pusher or pusher wire/tube 460 is held at a fixedposition. In this manner, the ventricular coils of the docking device 1,which is connected to or secured relative to the pusher wire/tube 460,can also be held in place without losing a desired position. The pushertool, pusher, and/or pusher wire/tube can be locked or fixed in position(e.g., by locking or fixing a proximal end thereof, such as in astabilizer, and/or by locking/holding/maintaining the knob in position),while the delivery catheter is pulled or retracted proximally. This canhold the anchoring device in position (e.g., because theanchoring/docking device abuts the stationary pusher or pusherwire/tube) while the delivery catheter is retracted thereby unsheathingthe second portion of the anchoring/docking device from the deliverycatheter. If a guide sheath is used, the guide sheath can also belocked/fixed in position (e.g., in the stabilizer) while the deliverycatheter is retracted. The pusher tool, delivery catheter, and/or guidesheath can be configured and/or arranged to be separately movable withrespect to each other and separately securable in a stabilizer or otherlocking/stabilization mechanism.

In FIGS. 17A and 17B, with the reference to the mitral valve, anothermethod of retracting the delivery catheter is shown. While the knob 450is held fixed, if appropriately configured, the handle body 440 of thepusher tool 430 (and the catheter handle 420 if one is present) can berotated relative to the knob 450 in a direction opposite to thedirection that the knob 450 was rotated, for example, in acounter-clockwise direction in the instant embodiment, causing thedistal region of the delivery catheter 410 to also rotate in the samedirection. The system and devices can be configured such that thisrotational motion causes translational motion of the delivery catheterproximally to retract the delivery catheter from off theanchoring/docking device. Since the docking device 1 is held in placewhen the delivery catheter 410 is rotated, the delivery catheter 410 canbe retracted relative to the docking device 1, thereby releasing thesecond portion or atrial turn(s) of the docking device 1 from thedelivery catheter 410, without the docking device 1 advancing anyfurther into the left ventricle or retracting back into the left atrium.

The handle body 440 of the pusher tool 430 can also be rotated relativeto the knob 450, which as best seen in FIGS. 10 and 11, will also resultin release and further distal advancement of the pusher or pusherwire/tube 460 from the pusher tool 430. The amount of advancement of thepusher or pusher wire/tube 460 can correspond substantially to thelength of the docking device 1 that is released into the left atrium, sothat the pusher or pusher wire/tube 460 provides sufficient slack toreplace the length of the docking device 1 that was held in the deliverycatheter 410 prior to deployment of the atrial turns, to furtherfacilitate holding of the docking device 1 in place during this process.

Connection of the docking device 1 to the pusher or pusher wire/tube 460via the retrieval line 468 (e.g., a retrieval suture) can alsofacilitate pulling of the docking device 1, for example, to readjust orretrieve the docking device 1 from the implant site. Such retrieval ispossible during any stage of delivery of the docking device 1, and canbe accomplished in similar manner as deployment of the docking device 1.For example, if adjustment of the ventricular coils of the dockingdevice 1 is desired, the position of the docking device 1 can beretracted or pulled backwards by rotating the knob 450 in the oppositedirection to advancement, for example, counter-clockwise in thisembodiment. In one embodiment, to hold the docking device 1 at the sameposition, while retracting a proximal portion (e.g., part of thestabilization coil/turn or atrial coil/turn) of the docking device 1back into the delivery catheter 410, the handle body 440 of the pushertool 430 or the knob can be rotated in the opposite direction toadvancement (e.g., clockwise in this embodiment). Partial or fullretrieval of the docking device into the delivery catheter is possible.

Once the docking device 1 has been delivered to a desired position, theretrieval line/suture 468 can be released, for example, with the lockingknob 457 or the suture/line locking mechanism 470 (e.g., by cuttingalong slot/window/cut-out 469 to cut a portion of the suture), thedocking device 1 can be separated from the pusher wire/tube 460, and thedelivery device 400 can be removed from the implant site. The THV 80 canthen be delivered to and expanded in the docking device 1 to completethe valve replacement procedure.

The delivery device 400 can be configured for delivering differentshaped and oriented docking devices in other embodiments. For example,while the above example discusses clockwise advancement of the dockingdevice 1, the docking device 1 can be adapted for delivering a coilanchor that is advanced counter-clockwise as well, for example, thedocking device 1 shown in FIG. 3. In this arrangement, rotation of therespective parts would be in the opposite direction to the methoddiscussed in FIGS. 16A to 17B. For example, the knob 450 would berotated in a counter-clockwise direction to advance the docking device 1out of the delivery catheter 410, while the knob would be rotatedclockwise to retract the docking device 1 back into and/or further intothe delivery catheter.

FIGS. 18-20 illustrate an exemplary embodiment of a system 500 (whichcan include the same or similar features/components as system 400) fordelivering a docking device 501 to a native valve of a patient's heart.The system 500 includes a guide sheath 502 which houses and protects adelivery catheter 504, which can be similar to or the same as the sheath480 and the delivery catheter 410, previously described. The deliverycatheter 504 includes an open distal end 506 and central lumen 508. Thesystem 500 also includes a pusher tool 510 and a pusher or pusherwire/tube 512, which can be the same as or similar to or the same as thepusher or pusher wire/tube 460, 460′, previously described.

The pusher wire/tube 512 includes a proximal end 514 fixedly attached tothe pusher tool 510 and a distal end 516 having a device abutmentsurface 518. The pusher wire/tube 512 can include a central lumen 520extending through the pusher wire/tube 512 from the proximal end 514 tothe distal end 516. The central lumen 520 can be open at the proximalend 514 via a proximal opening 522 and can be open at the distal end viaa distal opening 524.

The docking device 501 can include a proximal end 526 having one or moreholes 528 extending transversely through the proximal end 526. Thesystem 500 can include a retrieval line/suture 530 that connects thedocking device 501 to the pusher tool 510. The retrieval line/suture 530can extend from the pusher tool 510, through the proximal opening 522,through the central lumen 520, out of the distal opening 524, throughthe hole 528 in the docking device 501 and return to the pusher tool 510along the same path (e.g., forming a loop). Thus, the retrievalline/suture 530 can have a first leg 532 and a second leg 534 extendingfrom the pusher tool 510 to the docking device 501.

The pusher tool 510 can include a suture/line locking mechanism the sameas or similar to suture/line locking mechanism 470. For example, pushertool 510 can include a rotatable member 536 (e.g., the same as orsimilar to rotatable member 473 of suture/line locking mechanism 470 orthe rotatable member can take any other form), which the retrievalline/suture 530 may wind around. By rotating the rotatable member 536,the amount of the retrieval line/suture 530 that extends from the pushertool 510 can be lengthened or shortened. As shown in FIG. 18, therotatable member 536 can be rotated such that the retrieval line/suture530 draws the proximal end 526 of the docking device 501 against thedevice abutment surface 518. In this position, the docking device 501 isheld securely against the pusher wire/tube 512 such that the dockingdevice 501 and the pusher wire/tube 512 move in unison. In this manner,movement of the pusher tool 510 relative to the delivery catheter 504along the longitudinal axis A (FIG. 18) of the system 500 can move thedocking device 501 within the central lumen 508 of the delivery catheter504.

As shown in FIG. 19, the pusher tool 510 and the pusher wire/tube 512can be advanced relative to the delivery catheter 504 such that thedocking device 501 is advanced out of the central lumen 508 and past theopen distal end 506 of the delivery catheter 504. The retrievalline/suture 530, however, remains in tension such that the proximal end526 of the docking device 501 is held against the device abutmentsurface 518 of the pusher wire/tube 512.

As shown in FIG. 20, once the docking device 501 has been pushed out ofthe delivery catheter 504 by the pusher or pusher wire/tube 512, thepusher tool 510 can create slack in the retrieval line/suture 530 byallowing out additional length of the retrieval line/suture 530. Whentension in the retrieval line/suture 530 has been removed, the proximalend 526 of the docking device 501 is no longer held in engagement withthe device abutment surface 518 of the pusher wire/tube 512. Duringdelivery, the docking device 501 can be held in the delivery catheter504 in a relatively straight configuration for easier maneuverabilitythrough the delivery catheter 504. After exiting the delivery catheter504 and tension in the retrieval line/suture 530 is removed, the dockingdevice 501 can return to its original coiled or curved shape andplacement of the docking device 501 can be completed.

Since, however, the retrieval line/suture 530 remains connected to thedocking device 501, the docking device 501 can be retrieved orreadjusted from the implant site by retracting the retrieval line/suture530 back through the central lumen 520 of the pusher wire/tube 512 untilthe proximal end 526 of the docking device 501 is pulled into abutmentwith the device abutment surface 518 of the pusher wire/tube 512. Thepusher wire/tube 512 can then be pulled back through the central lumen508 of the delivery catheter 504 and, if necessary, the docking device501 can be wholly or partially pulled into the delivery catheter 504 forremoval or replacement.

If the docking device 501 is properly implanted, the docking device 501can be disconnected from the retrieval line/suture 530, such as forexample, by cutting or severing the retrieval line/suture 530 or aportion thereof. Once the docking device 501 is disconnected from theretrieval line/suture 530, the pusher tool 510 and retrieval line/suture530 can be withdrawn, leaving the docking device 501 in place. Forexample, one end of the retrieval line/suture 530 may be cut at or nearthe rotatable member 536 (e.g., in a slot/window/cut-out the same as orsimilar to slot/window/cut-out 469). Once the end is cut, the rotatablemember 536 can be rotated to draw the cut end down the pusher wire/tube512 to the hole 528, through the hole 528, and back into the pusherwire/tube 512 to permanently release the docking device 501. In anotherembodiment, both or either of the ends of the retrieval line/suture 530may be cut with either end being drawn through the hole 528 to releasethe docking device 501.

The pusher tool 510 can be configured in a variety of ways. Any toolcapable of advancing the docking device 501 through the deliverycatheter 504 while allowing controlled deployment and retrieval of thedocking device 501 can be used. Referring to FIGS. 21 and 22, as shownin the illustrated exemplary embodiment, the pusher tool 510 includes abody 600 having a forward portion 602 adapted to receive and fixedlyattach to the proximal end 514 of the pusher wire/tube 512 and arearward portion 604 including a suture/line locking mechanism 606,which can be the same as or similar to the suture/line locking mechanism470 described above. The body 600 can be generally elongated and caninclude a pathway 608 (FIG. 22) extending from the forward portion 602to the suture/line locking mechanism 606. The body 600 and pathway 608can be formed as a single unitary structure or can be formed from aplurality of attached components and fittings. The number and type ofcomponents and fittings can vary in different embodiments.

The forward portion 602 can fixedly attach to the proximal end 514 ofthe pusher or pusher wire/tube 512 in any suitable manner, such as afriction fit, a threaded connection, adhesives, fasteners, or othersuitable connections. As shown in the illustrated embodiment, theforward portion 602 can include a first connector 610 having a bore 612sized to closely receive the proximal end 514 of the pusher wire/tube512 such that the central lumen 520 of the pusher wire/tube 512 cancommunicate with the pathway 608 in the body 600. As shown in theillustrated embodiment, the central lumen 520 can be coaxially alignedwith the pathway 608 along an axis B (FIG. 22) of the pathway 608.

As shown in the illustrated exemplary embodiment, the first connector610 can be attached to a flush fitting 620. The first connector 610 mayattach to the flush fitting 620 by any suitable manner, such as afriction fit, a threaded connection, adhesives, fasteners, or othersuitable connections. As shown in the illustrated embodiment, the flushfitting 620 can be a T-fitting having a flush port 622 in fluidcommunication with the pathway 608. The flush port 622 can be connectedto or connectable to a flushing system 624 (FIG. 21) for introducing aflushing fluid, such as saline, for example, into the pathway 608. Asealing assembly 626 (FIG. 22) can be provided in the flush fitting 620,or otherwise between the flush fitting and the locking mechanism 606, toprevent flushing fluid from entering the locking mechanism 606.

The suture/line locking mechanism 606 can be attached to the rest of thebody 600 of the pusher tool 510 in any suitable manner, such as afriction fit, a threaded connection, adhesives, fasteners, or othersuitable connections. As shown in the illustrated embodiment, thesuture/line locking mechanism 606 can be attached to the flush fitting620 via a second connector 630 and a sealing cap 632. In one exemplaryembodiment, the connector 630 and sealing cap 632 allow the suture/linelocking mechanism 606 to swivel relative to the remainder of the body600. The second connector 630 can include a distal end 634 that isreceived within a bore 636 of the flush fitting 620, a proximal end 638that is received within a bore 640 on the suture/line locking mechanism606, and a rearward facing shoulder 642 positioned between the distalend 634 and the proximal end 638.

The sealing cap 632 can include a first end 644 that threadably engagesthe flush fitting 620 and a second end 646 having a bore 648 which thesecond connector 630 extends through. The shoulder 642 can abut an innersurface 650 of the sealing cap 632 adjacent the bore 648 to attach thesecond connector 630 to the flush fitting 620. While the sealing cap 632swivels, the distal end 634 presses against a gasket, which closes andseals the path of the retrieval line/suture 530.

The suture/line locking mechanism 606 can be configured in a variety ofways. Any mechanism capable of anchoring the retrieval line/suture 530,controlling the deployment and the retrieval of the retrievalline/suture 530, and locking the retrieval line/suture 530 at a setdeployment can be used. Referring to FIGS. 23 and 24, in one embodiment,the suture/line locking mechanism 606 includes a body 660 (which can begenerally T-shaped) having a first portion 662 and a second portion 664that extends away from a central region of the first portion 662. Therotatable member 536 is received in the first portion 662 and rotatableabout an axis C relative to the first portion 662 of the body 660.

The second portion 664 can include a bore 640 for receiving the proximalend 638 of the second connector 630. The bore 640 can extend the suturepathway 608 through the second portion 664 of the body 660 to therotatable member 536 in the first portion 662 of the body 660.

The second portion 664 can include a slot, window, or cut-out 670 (e.g.,the same as or similar to slot/window/cut-out 469) that provides accessto the bore 640 from the exterior of the second portion 664. Theslot/window/cut-out 670 can be configured in a variety of ways. Forexample, the location, the size, and the shape of theslot/window/cut-out 670 can vary for different embodiments. Any openingthat provides access to the bore 640 such that a user may access theretrieval line/suture 530 within the bore 640 can be used. In theillustrated embodiment, the slot/window/cut-out 670 is formed as asemi-circular, vertical channel.

A divider 672 can be positioned within the bore 640 adjacent theslot/window/cut-out 670. The divider 672 can be configured in a varietyof ways. Any structure that separates the two legs of the retrievalline/suture 530 within the bore 640 allowing one of the legs to bepresented in the slot/window/cut-out 670 can be used. In the illustratedembodiment, the divider 672 is a dowel pin arranged vertically in thebore 640 and sized and positioned such that one leg of the retrievalline/suture 530 can pass on one side of the divider 672 and the otherleg of the retrieval line/suture 530 can pass on the opposite side ofthe divider 672.

As shown in the illustrated embodiment, the first portion 662 can beformed by a generally cylindrical sidewall 680 defining a bore 682extending from a first end 684 of the first portion 662 to a second end686 opposite the first end 684. In some embodiments, however, the firstportion 662 can be shaped other than cylindrical. The first portion 662can include a radial lip 690 extending from the exterior of thecylindrical sidewall 680 proximate the first end 684.

The suture/line locking mechanism 606 can also include components orstructure for locking the rotational position of the rotatable member536 relative to the first portion 662. The components or structure canbe configured in a variety of ways. Any components or structure capableof locking the rotational position of the rotatable member 536 relativeto the first portion 662 can be used, such as for example, a splinedconnection. As shown in the illustrated embodiment, the first end 684 ofthe first portion 662 can include a gear-shaped first opening 692 in anend wall 694 of the first end 684. The first opening 692 can be axiallyaligned with the bore 682 along the axis C. The gear shape of theopening 692 can be formed by alternating radially extending projections696 and recesses 697 spaced circumferentially around the first opening692. As will be described in detail below, the projections 696 can actas stops that prevent rotation of the rotatable member 536. The numberand size of the projections 696 and recesses 697 can vary in differentembodiments. As shown in the illustrated embodiment, the gear shape ofthe opening 692 can be formed by nine alternating projections 696 andrecesses 697. Each projection 696 and each recess 697 can be about 40degrees apart from the next projection and recess, respectively.

The first end 684 can include a counter-bore 698 adjacent the firstopening 692. The counter-bore 698 can be coaxially aligned with the bore682 but can have a larger diameter than the bore 682. The first portion662 of the suture/line locking mechanism 606 can also include a hole 700that extends through the cylindrical sidewall 680 opposite and coaxialwith the bore 640 of the second portion 664.

The second end 686 of the first portion 662 can include a second opening702 opposite the first opening 692 and coaxial with the bore 682. Thesecond opening 702 can have the same size and shape as the bore 682 orcan have a different size and shape. As shown in the illustratedembodiment, the second end 686 can include a tapered or beveled exterioredge 704.

One or more stops 706 can be positioned between the hole 700 and thesecond opening 702 along the inner surface of the sidewall 680. The oneor more stops 706 can be configured in a variety of ways, such as forexample, the shape, size, and number of stops. Any structure capable ofrestricting axial movement of the rotatable member 536 can be used. Asshown in the illustrated embodiment, the one or more stops 706 caninclude a pair of dowel pins. For example, the first portion 662 caninclude a pair of offset bores 708 (FIG. 23), each sized to receive oneof the stops 706 and extending through the first portion 662 to form tworecessed grooves 710 along an inner surface of the bore 682 oppositeeach other. When received in the offset bores 708, the stops 706 reducethe cross-sectional size of the bore 682 to create a choke-point.

The rotatable member 536 of the suture/line locking mechanism 606 can beconfigured in a variety of ways. Any configuration capable of engagingthe retrieval line/suture 530 to deploy and retrieve the retrievalline/suture 530 can be used. For example, the rotatable member 536 canbe configured such that manually rotating the rotatable member 536 windsor unwinds the retrieval line/suture 530 from around a portion of therotatable member. As shown in the illustrated embodiment, the rotatablemember 536 can include a handle 720 and a stem 722 extending from thehandle 720. The handle 720 can be positioned at one end of the rotatablemember 536 and extend outside of the first portion 662 of the T-shapedbody 660. The handle 720 can be configured in a variety of ways. Anyconfiguration that facilitates turning or rotating of the rotatablemember 536 relative to the first portion 662 of the T-shaped body 660can be used.

The stem 722 can be generally cylindrical and sized to be receivedwithin the bore 682 of the first portion 662. As shown in theillustrated embodiment, the stem 722 can include a proximal portion 724adjacent the handle 720, a first reduced diameter portion 726 adjacentthe proximal portion 724, a second reduced diameter portion 728separated from the first reduced diameter portion 726 by a radial lip730, and a distal end portion 732 adjacent the second reduced diameterportion 728. The stem 722 can include an inner passage 734 extendingaxially from the proximal portion 724 through the distal end portion 732to form an opening 736 in the distal end portion 732.

The proximal portion 724 can include a radially extending projection 740(FIG. 22). The projection 740 is configured to interact with thegear-shaped first opening 692. In particular, the projection 740 issized to be received within one of the recesses 697 between two of theprojections 696. The projection 740 can be configured in a variety ofways. For example, the projection 740 can be integrally formed with thestem 722 or can be a separate component that is attached, or otherwiseconnected, to the rotatable member 536. As shown in the exemplaryembodiment, the stem 722 can include a radially extending bore 742proximate the handle 720 that receives the projection 740 in the form ofa dowel pin.

The first reduced diameter portion 726 can include a cross-bore 744 thatcommunicates with the inner passage 734. In the illustrated embodiment,the cross-bore 744 extends through the first reduced diameter portion726 generally perpendicular to the longitudinal axis C and has the sameor similar diameter to the pathway 608. In some embodiments, however,the cross-bore 744 may be shaped, sized, and oriented differently.

As shown in FIG. 22, the rotatable member 536 can include an anchoringor engagement feature 750 for anchoring or holding one or more ends ofthe retrieval line/suture 530. The anchoring or engagement feature 750can be configured in a variety of ways. Any feature capable of anchoringor holding one or more ends of the retrieval line/suture 530 can beused. As shown in the illustrated embodiment, the anchoring orengagement feature 750 can be cylindrical or generally cylindrical andcan be sized to be received in the inner passage 734 at the distal endportion 732 of the rotatable member 536. The anchoring or engagementfeature 750 can include a pair of passages 752 extending generallyparallel to the inner passage 734. Each of the passages 752 can be sizedto receive an end of the retrieval line/suture 530. In some embodiments,the anchoring or engagement feature 750 can include more or less than apair of passages 752.

Referring to FIG. 22, when assembled, the stem 722 of the rotatablemember 536 can be slideably and rotatably received within the bore 682of the first portion 662 of the suture/line locking mechanism 606 andthe handle 720 extends from the first end 684. The cross bore 744 of therotatable member 536 can be in communication with the pathway 608 andthe anchoring or engagement feature 750 can be positioned in the innerpassage 734 at the distal end portion 732 of the rotatable member 536.

The first leg 532 and the second leg 534 of the retrieval line/suture530 can extend from the docking device 501, through the pusher or pusherwire/tube 512, through the pathway 608, and into the rotatable member536 via the cross-bore 744. From the cross-bore 744, the first leg 532and the second leg 534 of the retrieval line/suture 530 can enter theinner passage 734 and extend along the inner passage 734 to theanchoring or engagement feature 750 at the distal end portion 732. Atthe anchoring or engagement feature 750, the first leg 532 of theretrieval line/suture 530 can extend through one of the pair of passages752 and the second leg 534 of the retrieval line/suture 530 can extendthrough the other of the pair of passages 752. Once through the passages752, the first leg 532 and the second leg 534 can be anchored in place,such as for example, by being tied together or knotted at their ends.

In one embodiment, as the first leg 532 and the second leg 534 of theretrieval line/suture 530 extend through the pathway 608 past thedivider 672, the first leg 532 of the retrieval line/suture 530 passesalong one side of the divider 672 and the second leg 534 passes alongthe opposite side of the divider 672 such that the divider 672 separatesthe two legs 532,534.

The stem 722 of the rotatable member 536 can be positioned within thebore 682 such that the second reduced diameter portion 728 is adjacentthe recessed grooves 710 on the inner surface of the bore 682. The stops706, when inserted in the recessed grooves 710, extend, at least partly,into the second reduced diameter portion 728 and between the radial lip730 and the distal end portion 732 of the stem 722. Thus, axial movementof the rotatable stem 722 of the rotatable member 536 within the bore682 can be limited by the stops 706.

The rotatable member 536 can be axially moveable within the bore 682between a first position and a second position. The suture/line lockingmechanism 606 can include a biasing member 754 that biases the rotatablemember 536 to the first position. The biasing member 754 can beconfigured in a variety of ways. Any biasing member capable of biasingthe rotatable member 536 to the first position can be used. As shown inthe illustrated embodiment, the biasing member 754 can be a springpositioned between the radial lip 690 and an underside surface 756 ofthe handle 720 to bias the handle 720 away from the T-shaped body 660.

Referring to FIGS. 25 and 26, in the illustrated first position, thedistal end portion 732 of the stem 722 engages the stops 706 to preventfurther upward axial movement of the rotatable member 536. Thecross-bore 744 is positioned to communicate with the pathway 608. In theillustrated embodiment, the cross-bore 744 is coaxially aligned with thepathway 608. In some embodiments, however, the cross-bore 744 need notbe coaxially aligned with the pathway 608 in the first position.

At the proximal portion 724 of the stem 722, the projection 740 can bepositioned in one of the plurality of recesses 697 between adjacentprojections 696. Thus, the radially extending projections 696 canprevent rotation of the rotatable member 536 by engaging the projection740. The first position, therefore, can be a locked position.

Referring to FIG. 27, in the illustrated second position, the rotatablemember 536 is moved downward relative to the T-shaped body 660 againstthe bias of the biasing member 754. The radial lip 730 engages the stops706 to prevent further downward axial movement of the rotatable member536. The cross-bore 744, while not aligned with the pathway 608, isstill positioned to communicate with the pathway 608. At the proximalportion 724 of the stem 722, the projection 740 is positioned in thecounter bore 698 of the first portion 662 below the plurality ofrecesses 697 and radially extending projections 696 of the first opening692 (see FIGS. 23 and 24). Thus, the rotatable member 536 is able torotate about the axis C. The second position, therefore, is a rotatableposition.

In operation, a user can move the handle 720 to the second position, forexample, by pushing it downward relative to the T-shaped body 660. Inthe second position, the rotatable member 536 can be rotated by thehandle 720. Rotating the rotatable member 536 in a first direction, suchas for example, clockwise, can wind a portion of the retrievalline/suture 530 around the first reduced diameter portion 726 of thestem 722; thus, retrieving or reducing the amount of retrievalline/suture 530 that extends from the suture/line locking mechanism 606.Rotating the rotatable member 536 in a second direction opposite thefirst direction, such as for example, counterclockwise, can unwind aportion of retrieval line/suture 530 from first reduced diameter portion726 of the stem 722; thus, deploying or increasing the amount ofretrieval line/suture 530 that extends from the suture/line lockingmechanism 606. In one embodiment, to lock the amount of retrievalline/suture 530 that has been deployed, the user can release the handle720 allowing the biasing member 754 to move the rotatable member 536 tothe first position; thus preventing the rotatable member 536 fromrotating. Locking the retrieval line/suture 530 by wrapping theretrieval line/suture 530 around the rotatable member 536 and preventingthe rotatable member 536 is a friction locking method that reduces therisk of the retrieval line/suture 530 tearing when compared to lockingmethods which are based on clamping the retrieval line/suture 530,especially with thin retrieval lines/sutures.

To release the docking device 501 from the retrieval line/suture 530,the first leg 532, the second leg 534, or both legs of the retrievalline/suture 530 can be cut at the slot/window/cut-out 670 in the secondportion 664 of the body 660. For example, in the illustrated embodiment,since the first leg 532 and the second leg 534 of the retrievalline/suture 530 are separated in the pathway 608 adjacent theslot/window/cut-out 670 by the divider 672, only a single leg ispresented at the slot/window/cut-out 670, with the other leg beingpositioned behind the divider 672. The single leg in front of thedivider 672, therefore, can be cut without concern for cutting the otherleg. Once one of the first or the second leg 532, 534 is cut, the cut orsevered end of the retrieval line/suture 530 can be pulled through thecentral lumen 520 toward the docking device 501, through the hole 528 inthe docking device 501 to release the docking device 501, and backthrough the central lumen 520 of the pusher wire. This can beaccomplished by in a number of ways. For example, the handle 720 cansimply be pressed down and rotated to wind the retrieval line/suture 530onto the stem 722. Or, the suture/line locking mechanism 606 can bedisconnected from the pusher tool 510 by disconnecting the first end 644of the sealing cap 632 from the flush fitting 620. Since the retrievalline/suture 530 is attached to the suture/line locking mechanism 606,removing the suture/line locking mechanism 606 from the rest of thepusher tool 510 will pull the retrieval line/suture 530 through the hole528 and disconnects the docking device 501.

Optionally, the various pushers (e.g., pusher wires, pusher tubes, etc.)described herein can have a coating over and/or inside it, e.g., thepushers can have an interior lumen lined by PTFE to allow a line (e.g.,a suture) to be atraumatically actuated through the lined lumen.

The various manipulations and controls of the systems and devicesdescribed above can be automated and/or motorized. For example, thecontrols or knobs described above can be buttons or electrical inputsthat cause the actions described with respect to the controls/knobsabove. This can be done by connecting (directly or indirectly) some orall of the moving parts to a motor (e.g., an electrical motor, pneumaticmotor, hydraulic motor, etc.) that is actuated by the buttons orelectrical inputs. For example, the motor can be configured, whenactuated, to cause the control wires or pull wires described herein totension or relax to move the distal region of the catheter. Additionallyor alternatively, the motor could configured, when actuated, to causethe pusher to move translationally or axially relative to the catheterto cause an anchoring or docking device to move within and/or into orout of the catheter. Automatic stops or preventative measures could bebuilt in to prevent damage to the system/device and/or patient, e.g., toprevent movement of a component beyond a certain point.

Additional systems, devices, components, methods, etc. are described inU.S. Provisional Patent Application Ser. No. 62/435,563, filed on Dec.16, 2016, and titled “DEPLOYMENT TOOLS AND METHODS FOR DELIVERING ANANCHORING DEVICE FOR A PROSTHETIC VALVE AT A NATIVE VALVE ANNULUS” andthe related PCT Patent Application Serial No. PCT/US2017/066854 titled“DEPLOYMENT SYSTEMS, TOOLS, AND METHODS FOR DELIVERING AN ANCHORINGDEVICE FOR A PROSTHETIC VALVE” filed on Dec. 15, 2017, each of which areincorporated by reference herein, and the systems, devices, components,methods, etc. can be integrated or used with the systems, devices,methods, etc. described herein mutatis mutandis.

In various other embodiments, any or all of the differentfeatures/components from the different embodiments discussed above canbe combined or modified, based for example, on the shape andconfiguration of the docking device to be delivered and/or on theanatomy or needs of each individual patient. Features/componentsdescribed with respect to one embodiment can be included in otherembodiments even if not described with respect to that embodiment.Similarly steps described with respect to one method can be included inother methods even if not described with respect to that method. Stepsdescribed at various points in the disclosure, even if separated fromeach other, can be combined.

Furthermore, while only transseptal delivery of the docking device 501has been discussed in detail, the tools and methods can be modified inother embodiments for other delivery procedures, for example,transatrial or transapical delivery. In addition, as has been discussed,while embodiments of the docking device 501 and delivery devices havegenerally been discussed above with respect to valve replacement at themitral position, similar docking devices and delivery methods can alsobe applied at other valve sites as well, for example, at the tricuspid,pulmonary, or aortic valve positions. Docking devices similar to or thesame as those discussed above, when applied to valves other than themitral valve, can also provide a more secure landing zone for THVs atthose sites as well.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatus, and systems should not be construed asbeing limiting in any way. Instead, the present disclosure is directedtoward all novel and nonobvious features and aspects of the variousdisclosed embodiments, alone and in various combinations andsub-combinations with one another. The methods, apparatus, and systemsare not limited to any specific aspect or feature or combinationthereof, nor do the disclosed embodiments require that any one or morespecific advantages be present or problems be solved.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage set forth below. For example, operations described sequentiallycan in some cases be rearranged or performed concurrently. Moreover, forthe sake of simplicity, the attached figures may not show the variousways in which the disclosed methods can be used in conjunction withother methods. Additionally, the description sometimes uses terms like“provide” or “achieve” to describe the disclosed methods. These termsare high-level abstractions of the actual operations that are performed.The actual operations that correspond to these terms can vary dependingon the particular implementation and are readily discernible by one ofordinary skill in the art.

In view of the many possible embodiments to which the principles of thedisclosure can be applied, it should be recognized that the illustratedembodiments are only preferred examples and should not be taken aslimiting the scope of the disclosure. Rather the scope of the disclosureis defined by the following claims.

What is claimed is:
 1. A delivery device for delivering a docking deviceto a native valve annulus of a patient's heart, the delivery devicecomprising: a delivery catheter having a first lumen; and a pusher toolcomprising: a pusher slideably received within the first lumen, thepusher having a distal portion, and proximal portion, and a second lumenextending from the proximal portion to the distal portion; a lockingmechanism fixedly attached to the proximal portion of the pusher; and aretrieval line extending through the second lumen from the lockingmechanism to the docking device to connect the docking device to thepusher tool; wherein the locking mechanism includes a rotatable memberconnected to the retrieval line, the rotatable member having a firstposition that locks the amount of retrieval line that extends from thelocking mechanism and a second position that allows the amount ofretrieval line that extends from the locking mechanism to be increasedor decreased.
 2. The delivery device of claim 1 wherein the pushercomprises a helically wound wire.
 3. The delivery device of claim 1wherein the pusher comprises a patterned cut tube.
 4. The deliverydevice of claim 1 wherein the locking mechanism comprises a line accesswindow for accessing a single end of the retrieval line.
 5. The deliverydevice of claim 4 further comprising a divider in the window, wherein afirst end of the retrieval line is on a first side of the divider and asecond end of the retrieval line is on a second side of the divider. 6.The delivery device of claim 1 wherein the rotatable member comprises afirst passage extending along a rotational axis of the rotatable memberand a second passage that intersects the first passage, wherein theretrieval line extends through the first and second passages.
 7. Thedelivery device of claim 1 wherein the locking mechanism comprises adetent that prevents the rotatable member from rotating when therotatable member is in the first position.
 8. The delivery device ofclaim 7 wherein the detent allows the rotatable member to rotate whenthe rotatable member is in the second position.
 9. The delivery deviceof claim 1 wherein the rotatable member is biased to the first position.10. A method of delivering a docking device to a native valve of apatient's heart, the method comprising: connecting the docking device toa pusher tool with a line; positioning the docking device and the pushertool within a delivery catheter; positioning a distal region of adelivery catheter in an atrium of the heart; advancing a pusher of thepusher tool distally through the delivery catheter, wherein the pusherpushes the docking device in a lumen of the delivery catheter; androtating a member of the pusher tool to change the amount of the lineextending from the pusher tool.
 11. The method of claim 10 wherein thepusher comprises a helically wound wire.
 12. The method of claim 10further comprising cutting the line to disconnect the docking devicefrom the pusher tool.
 13. The method of claim 12 further comprisingrotating the member to pull a cut end of the line through the dockingdevice and back into the pusher tool.
 14. The method of claim 10 whereinthe line extends into an opening in an outer circumferential surface ofthe shaft of the member.
 15. The method of claim 10 wherein the lineextends inside the shaft along a length of the shaft and out an end ofthe shaft.
 16. The method of claim 10 further comprising preventing themember from rotating when the member is released.
 17. The method ofclaim 10 further comprising pressing the member to allow the member torotate.
 18. A delivery device for delivering an anchoring device to anative valve annulus of a patient's heart, where the anchoring device isusable to secure a prosthetic heart valve at the native valve annulus,the delivery device comprising: a delivery catheter having a distalregion configured such that it can transition from a first shape to asecond shape different from the first shape, the second shape beingcurved; and a pusher tool, the pusher tool comprising: a bodyrotationally fixable relative to the delivery catheter; a controlconnected to the body; and a pusher connected to the control; whereinthe pusher is configured to extend through the body to the deliverycatheter, and to move translationally in the delivery catheter when theknob is actuated, to move the anchoring device within and/or out of thedelivery catheter.
 19. The delivery device of claim 18, wherein thecontrol is a knob rotatable relative to the body and the delivery deviceis configured such that rotation of the knob relative to the body causesthe pusher to move translationally to move the anchoring device.
 20. Thedelivery device of claim 18, further comprising a suture for connectinga distal end of the pusher to the anchoring device.
 21. The deliverydevice of claim 20, wherein the pusher tool further comprises a lockingfeature for holding at least one end of the suture.
 22. The deliverydevice of claim 18, further comprising a controller for adjusting acurvature of the distal region of the delivery catheter and a catheterhandle connected to the delivery catheter, wherein the controller is onthe catheter handle, and wherein the catheter handle is configured to berotationally fixed relative to the body of the pusher.